Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-08-31

Brief Summary

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Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo in patients with moderate to severe post-surgical pain following orthopedic surgery. After initial dosing, up to six (6) doses of IN MNS075 7.5 mg or 15 mg for up to twenty-four (24) hours will be evaluated. The rescue dose remained the same for each.

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Detailed Description

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Diagnosis and Main Criteria for Inclusion:

Healthy adult patients (18 to 76 years old), who scored PS-1 to PS-3 according to the American Society of Anesthesiologists Physical Status Classification System, requiring primary, unilateral, first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair without additional collateral procedures.

Conditions

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Hallux Valgus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Intranasal morphine 3.75 mg

Group Type EXPERIMENTAL

Intranasal Morphine (MNS075) 3.75 mg

Intervention Type DRUG

Intranasal Morphine (MNS075) 3.75 mg

2

Intranasal morphine 7.5 mg

Group Type EXPERIMENTAL

Intranasal morphine (MNS075) 7.5 mg

Intervention Type DRUG

Intranasal morphine (MNS075) 7.5 mg

3

Intranasal morphine 15 mg

Group Type EXPERIMENTAL

Intranasal morphine (MNS075) 15 mg

Intervention Type DRUG

Intranasal morphine (MNS075) 15 mg

4

Intranasal morphine 30 mg

Group Type EXPERIMENTAL

Intranasal morphine (MNS075) 30 mg

Intervention Type DRUG

Intranasal morphine (MNS075) 30 mg

5

Intravenous morphine 7.5 mg

Group Type ACTIVE_COMPARATOR

Intravenous Morphine 7.5 mg

Intervention Type DRUG

Intravenous Morphine 7.5 mg

6

Intranasal placebo

Group Type PLACEBO_COMPARATOR

Intranasal placebo

Intervention Type DRUG

Intranasal placebo

Interventions

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Intranasal Morphine (MNS075) 3.75 mg

Intervention Type DRUG

Intravenous Morphine 7.5 mg

Intervention Type DRUG

Intranasal morphine (MNS075) 7.5 mg

Intervention Type DRUG

Intranasal morphine (MNS075) 15 mg

Intervention Type DRUG

Intranasal morphine (MNS075) 30 mg

Intervention Type DRUG

Intranasal placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Requires primary unilateral first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair under regional anesthesia. The patient requires collateral orthopedic surgical procedures other than ipsilateral hammertoe repair may not be enrolled into the study.
* 18 years of age or older
* Moderate to severe pain within eight (8) hours following completion of the required bunionectomy surgery

Exclusion Criteria

* Allergy to shellfish
* Signs of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety.
* Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No